MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL HINGE COMPONENT

Model Number 25002100E

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/29/2020

Event Type  malfunction  

Manufacturer Narrative

The root cause for the alleged infection was unable to be determined.The patient's medical history is unknown, and it is unknown whether the patient sustained a trauma prior to the failure.Based on review of the device history records and sterilization batch release records, it was concluded that the failure was not associated with the manufacture or sterilization of the implants, or a nonconformance.

Event Description

A patient underwent a revision surgery on (b)(6) 2020 performed by (b)(6) due to an alleged infection.The surgeon performed an incision and drainage procedure to remove the infected tissue.The tibial poly spacer, tibial hinge component, and the distal femur axial pin were all revised with identical implants.

• Brand Name: ELEOS
• Type of Device: TIBIAL HINGE COMPONENT
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline road; arlington TN 38002
• Manufacturer Contact: jonathan zachok ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 10632321
• MDR Text Key: 219178408
• Report Number: 3013450937-2020-00136
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B27825002100E0
• UDI-Public: B27825002100E0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151620
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25002100E
• Device Catalogue Number: 25002100E
• Device Lot Number: 1778816
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR